ParaRev Weekly eJournal July 27, 2022 by CorroHealth

ej o u r n a l july 27, 2022

Colonoscopy Coding

Losing Millions?

Modifiers, E/ M Coding And Medical Necessity

Inaccurate Medicare Transfer DRG Reductions

SPECIAL UPDATE

Changes In The W ind? W hat Could Change W ith Lab PAMA

PARA Weekly eJournal: July 27, 2022

MEDICARE RULE REGARDING COLONOSCOPIES

We have been working with our coders to better help them understand modifiers XS and

XU. When reporting two or more diagnostic colonoscopy codes, is it appropriate to append modifier XS (separate structure), or should we report modifier XU (unusual, non-overlapping service)? For example, we need to append a modifier to report 45380 with 45385 to resolve a CCI edit.

The modifier assignment will be dependent on the site of the polyp being removed. If all

polyps removed are in the large intestine and each removed by a different method (i.e., cold biopsy, hot biopsy, snare), append modifier XU. The large intestine starts at the sigmoid colon and ends at the cecum. This is considered one anatomic site. Consider these two scenarios. Scen ar io 1: The patient presents for a colonoscopy. The scope is advanced to the cecum. During the exam two polyps are identified. The first polyp is identified in the descending colon and removed by cold biopsy. The second polyp is identified in the transverse colon and removed by hot biopsy. In this scenario, report 45384 for the hot biopsy of polyp in the transverse colon and 45380 for the cold biopsy removal of a polyp in the descending colon. Append modifier XU to 45380 for overlapping services. Although the polyps are identified at different areas of the large intestine, they were in the same anatomic site. The services are considered overlapping since the polyps were removed in different methods (i.e., cold biopsy and hot biopsy). 2

PARA Weekly eJournal: July 27, 2022

MEDICARE RULE REGARDING COLONOSCOPIES

Scen ar io 2: The patient presents for a colonoscopy. The scope is advanced to the cecum. During the exam two polyps are identified. The first polyp is identified in the rectum and removed by cold biopsy. The second polyp is identified in the transverse colon and removed by hot biopsy.In this scenario, report 45384 for the hot biopsy of polyp in the transverse colon and 45380 for the cold biopsy removal of a polyp in the rectum. Append modifier XS to 45380 for separate anatomic site. One polyp was identified in the large intestine and the other polyp was in the rectum. Since the rectum is a different anatomic site from the large intestine, XS is appropriate.

We have been holding bills at our Rural Health Clinic for pre-operative clearance visits for Medicare patients scheduled for a colonoscopy. I have been asked to investigate whether these encounters are billable. We have heard that E/Ms ?before/prior to? a screening C-scope were not to be billed. However, for the 16 years I have been in clinic billing we have always billed them if they weren?t the ?day before or day of ? of procedure, as those would get bundled. We?ve gotten paid just fine and in all those years to my knowledge, none of our MC audits resulted in any take backs or fines regarding our billing them. We researched coding forums on-line as well, and any data I could find from or regarding MC and screening C-scopes and opinion, is divided. Many stated that the ?before/prior to? means within 24 hours of the procedure; and that they have billed for them as a rule and always been paid (as we did). Others said they felt that the ?before/prior to? meant any time, even weeks before, and they didn?t bill for them. Is the ?consulting/decision for surgery? visit to a specialist for a screening colonoscopy billable? We understand that a pre-operative clearance/H&P after the decision for surgery is made, is not billable as it is not deemed medically necessary. But can we bill for the visit in which the patient meets the specialist, and a decision is made as to whether or a colonoscopy should be done or not?Also, if the consult/decision for surgery is indeed billable, does it fall into the ?day before/day of ?rule where it?s not billable even with modifier 57, due to being a minor procedure, or is that rule only regarding pre-ops? Typically, our consults are done days to weeks prior to the scope, but sometimes it is more of 3 a list-minute decision .

PARA Weekly eJournal: July 27, 2022

MEDICARE RULE REGARDING COLONOSCOPIES

Medicare and most other insurers cover only medically necessary services. A patient is eligible for a screening colonoscopy if there are no signs or symptoms of GI trouble. It stands to reason that a pre-op clearance exam that finds no health care condition to support the medical necessity of the visit is not medically necessary, and therefore should not be billed, regardless of the timing (same day or not.) Medicare may have paid claims for such visits at the RHC in the past, but that doesn?t necessarily mean the visits have truly met the general test of medical necessity. However, if there is a medically necessary reason for the visit, such as any other complicating condition that would be pertinent to the safety of the patient while undergoing the procedure (high blood pressure, diabetes, etc.), then the visit might be considered medically necessary. Medical necessity will be determined by the documentation and diagnosis coding provided in addition to the ICD10 Z01.81x (Encounter for preprocedural examinations.) Medicare defines an RHC visit as ?medically necessary?.

The American Gastroenterological Association website also discusses this issue. If the service is not a screening colonoscopy, then several other factors influence whether a pre-operative H&P visit should be separately reported and/or reimbursed: - Whether the E/M is performed by the same physician/same group practice who will perform the surgical procedure, and - Whether the decision for surgery has already been made at the time of the H&P; and - Whether the E/M is performed on the same day or the day prior to the surgical procedure, and - Whether the global period for the surgical procedure 10 days or less - Whether the service was medically necessary, in other words, were there conditions that required assessment before the patient could safely have surgery; - If the procedure is preventive in nature, and there is no ?problem? to report on a problem-focused visit, then the visit does not meet medical necessity 4

PARA Weekly eJournal: July 27, 2022

MEDICARE RULE REGARDING COLONOSCOPIES

Another physician (not the surgeon) can bill for an H&P after the surgeon makes the decision to perform surgery, and refers the patient to a second physician (often a primary care physician) for a preoperative H&P. This service is reportable, but if the visit is not deemed to be medically necessary, a payer may deny payment. Medical necessity will be determined by the documentation and diagnosis coding provided in addition to the ICD10 Z01.81x: ICD-10 Codes Codes an d/ or Descr ipt ion s: Z0181

The following matrix was created to help simplify the various scenarios when a medically necessary pre-op exam would be billable.

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Tw o com pan ion bills, on e in t h e US Sen at e, t h e ot h er in t h e US Hou se of Repr esen t at ives, w er e in t r odu ced in Con gr ess on Ju n e 22, 2022.

These bills aim to significantly relieve the burden on certain ?Applicable Laboratories? (including many hospital laboratories) which are required by Medicare to submit detailed reports of commercial lab payment rates in 2023. Under current regulations, ?Applicable laboratories? must report the volume and rate of payments received for each lab test CPT® /HCPCS from commercial payers during a six-month period. The reports are due every three years; the report deadline for the 2019 reporting period is due during the first quarter of 2023. However, the deadline has been repeatedly extended due to COVID, and the bills may revise altogether the reporting requirement. Medicare needs providers to report payment data in order to calculate the weighted median rate paid by commercial payers for each test, as required under the Protecting Access to Medicare Act (2014.) The first attempt to collect that data in 2016 was arguably flawed, and resulted in significant cuts to reimbursement under the Clinical Laboratory Fee Schedule beginning in 2018. Although Medicare attempted to correct the flawed process by expanding the number and types of providers required to report data from 2019, ?Applicable Laboratories? have complained that the process is burdensome. Congress has delayed the reporting deadline three times since the requirement was expanded to include many hospitals, and now Congress appears to be poised to change the requirement significantly. The two companion bills would change the data collection method to a statistically representative process conducted every four years, rather than broad reporting responsibility every three years.

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

The bills are: - Sen at e Bill S.4449? Saving Access to Laboratory Services Act, (SALSA); introduced by Sen. Richard Burr (R-NC), cosponsored by Senator Sherrod Brown (D-OH).Status: referred to the Senate Committee on Finance https://www.congress.gov/bill/117th-congress/senate-bill/4449?s=1&r=5 - Hou se BillH.R.8188- Saving Access to Laboratory Services Act, introduced by Rep. Bill Pascrell Jr., (D-NY), and cosponsored by two more Democrats and two Republican representatives.Status: referred to both the Committee on Energy and Commerce and to the Ways and Means Committee. https://www.congress.gov/bill/117th-congress/house-bill/8188?s=5&r=553

So far, both bills appear to enjoy bipartisan support, and are supported by numerous organizations of providers, including: -

The American Clinical Lab Association The National Independent Lab Association The American Society for Clinical Laboratory Science William Morice II, M.D., president of Mayo Clinic Laboratories and Matt Sause, president and CEO of Roche Diagnostics North America, who wrote an editorial on the topic for RealClearPolicy.com.

Neither bill provides recognition or compensation to organizations which already invested significant time and money into preparing for the mandatory report for payments received in the first six months of 2019.Many providers who meet the ?Applicable Laboratory? definition have been diligently preparing (or have already prepared) details of 2019 payments in order to avoid costly penalties for failure to meet the deadline. Par aRev will continue to monitor progress on the bills and report back as actions are taken up in Congressional committees. 7

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text §1395m ?1. Im pr ovin g policies f or clin ical diagn ost ic labor at or y t est s (a) Repor t in g of pr ivat e sect or paym en t r at es f or est ablish m en t of m edicar e paym en t r at es (1) In gen er al (A) Gen er al r epor t in g r equ ir em en t s ·Subject to subparagraph (B)Subject to subparagraph (B) and (C), beginning January 1, 2016, and every 3 years thereafter (or, annually, in the case of reporting with respect to an advanced diagnostic laboratory test, as defined in subsection (d)(5)), an applicable laboratory (as defined in paragraph (2)) shall report to the Secretary, at a time specified by the Secretary (referred to in this subsection as the "reporting period"), applicable information (as defined in paragraph (3)) for a data collection period (as defined in paragraph (4)) for each clinical diagnostic laboratory test that the laboratory furnishes during such period for which payment is made under this part. (B) Revised r epor t in g per iod ·In the case of reporting with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the Secretary shall revise the reporting period under subparagraph (A) such that(i) no reporting is required during the period beginning January 1, 2020, and endingDecember 31, 2022December 31, 2024; (ii) reporting is required during the periodbeginning January 1, 2023, and ending March 31, 2023Beginning January 1, 2026 and ending March 31, 2026; and (iii) reporting is requiredevery three yearsevery four yearsafter the period described in clause (ii).

(C)USE OF STATISTICAL SAMPLING FOR WIDELY AVAILABLE CLINICAL DIAGNOSTIC LABORATORY TESTS.? ?(i)IN GENERAL.? Subject to clause (ii), with respect to data collection periods for reporting periods beginning on or after January 1, 2026, in the case of a widely available clinical diagnostic laboratory test (as defined in clause (iii)), in lieu of requiring the reporting of applicable information from each applicable laboratory, the Secretary shall require the collection and reporting of applicable information from a statistically valid sample of applicable laboratories for each such widely available clinical diagnostic laboratory test. ?(ii)REQUIREMENTS FOR STATISTICAL SAMPLING.? ?(I)IN GENERAL.? The Secretary, in consultation with stakeholders, shall develop a methodology for a statistically valid sample under clause (i), using the maximal brewer selection method, as described in the June 2021 Medicare Payment Access Commission Report to the Congress, to establish the payment amount for a widely available clinical diagnostic laboratory test under paragraph (2) of subsection (b) for each applicable HCPCS code for a widely available clinical diagnostic laboratory test. 8

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text ?(II) REPRESENTATIVE SAMPLING.? The methodology under subclause (I) for a statistically valid sample under clause (i) shall, for each applicable HCPCS code for a widely available clinical diagnostic laboratory test? ?(aa) provide for a sample that allows for the payment amounts established under paragraph (2) of subsection (b) for such a test to be representative of rates paid by private payors to applicable laboratories receiving payment under this section, including independent laboratories, hospital laboratories, hospital outreach laboratories, and physician office laboratories that furnish the widely available clinical diagnostic laboratory test; ?(bb) include applicable information (as defined in paragraph (3)) with respect to such widely available clinical diagnostic laboratory test from such different types of applicable laboratories; and ?(cc) be of sufficient size to accurately and proportionally represent the range of private payor payment rates received by each such type of applicable laboratory weighted according to the utilization rates of each type of applicable laboratory for the widely available clinical diagnostic laboratory test during the first 6 months of the calendar year immediately preceding the data collection period applicable to the sample to be collected. ?(III) LEAST BURDENSOME DATA COLLECTION AND REPORTING PROCESSES.? The methodology developed by the Secretary shall be designed to reduce administrative burdens of data collection and reporting on applicable laboratories and the Centers for Medicare & Medicaid Services to the greatest extent practicable. ?(IV)PUBLICATION OF LIST OF WIDELY AVAILABLE CLINICAL DIAGNOSTIC LABORATORY TESTS AND NOTIFICATION TO APPLICABLE LABORATORIES REQUIRED TO REPORT APPLICABLE INFORMATION.? Not later than September 30 of the year immediately preceding each data collection period (as defined in paragraph (4)), the Secretary shall publish in the Federal Register a list of widely available clinical diagnostic laboratory tests and shall directly notify applicable laboratories required to report applicable information under this subsection. ?(iii) DEFINITION OF WIDELY AVAILABLE CLINICAL DIAGNOSTIC LABORATORY TEST.? In this subparagraph, the term ?widely available clinical diagnostic laboratory test?means a clinical diagnostic laboratory test that meets both of the following criteria during the first 6 months of the calendar year immediately preceding the data collection period applicable to the sample to be collected:

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text ?(I)PAYMENT RATE.? The payment amount determined for the clinical diagnostic laboratory test under this section is less than $1,000 per test. ?(II)N UMBER OF LABORATORIES PERFORMING THE TEST.? The number of applicable laboratories receiving payments under this section for the clinical diagnostic laboratory test (as determined by the Secretary using the national provider identifier of the provider of services or supplier on the claim submitted for payment under this part for such test) exceeds 100.?. (2) Def in it ion of applicable labor at or y In this section, the term "applicable laboratory" means a laboratory that, with respect to its revenues under this subchapter, a majority of such revenues are from this section,section 1395l(h) of this title, orsection 1395w?4 of this title. The Secretary may establish a low volume or low expenditure threshold for excluding a laboratory from the definition of applicable laboratory under this paragraph, as the Secretary determines appropriate. (3) Applicable in f or m at ion def in ed (A) In gen er al ·In this section, subject to subparagraph (B), the term "applicable information" means, with respect to a laboratory test for a data collection period, the following: (i) The payment rate (as determined in accordance with paragraph (5)) that was paid by each private payor for the test during the period. (ii) The volume of such tests for each such payor for the period. (B) Except ion f or cer t ain con t r act u al ar r an gem en t s ·Such term shall not include information with respect to a laboratory test for which payment is made on a capitated basis or other similar payment basis during the data collection period. (4) Dat a collect ion per iod def in ed (A) In gen er al ·Subject to subparagraph (B), in this section, the term "data collection period" means a period of time, such as a previous 12 month period, specified by the Secretary. (B) Except ion ·In the case of the reporting period described in paragraph (1)(B)(ii) with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the term "data collection period" means the period beginning January 1, 2019, and ending June 30, 2019. (5) Tr eat m en t of discou n t s The payment rate reported by a laboratory under this subsection shall reflect all discounts, rebates, coupons, and other price concessions, including those described insection 1395w?3a(c)(3) 10 of this title.

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (6) En su r in g com plet e r epor t in g In the case where an applicable laboratory has more than one payment rate for the same payor for the same test or more than one payment rate for different payors for the same test, the applicable laboratory shall report each such payment rate and the volume for the test at each such rate under this subsection. Beginning with January 1, 2019, the Secretary may establish rules to aggregate reporting with respect to the situations described in the preceding sentence. (7) Cer t if icat ion An officer of the laboratory shall certify the accuracy and completeness of the information reported under this subsection. (8) Pr ivat e payor def in ed In this section, the term "private payor " means the following: ·(A) A health insurance issuer and a group health plan (as such terms are defined insection 300gg?91 of this title). ·(B) A Medicare Advantage plan under part C. ·(C) A medicaid managed care organization (as defined insection 1396b(m) of this title). (9) Civil m on ey pen alt y (A) In gen er al ·If the Secretary determines that an applicable laboratory has failed to report or made a misrepresentation or omission in reporting information under this subsection with respect to a clinical diagnostic laboratory test, the Secretary may apply a civil money penalty in an amount of up to $10,000 per day for each failure to report or each such misrepresentation or omission. (B) Applicat ion ·The provisions ofsection 1320a?7a of this title(other than subsections (a) and (b)) shall apply to a civil money penalty under this paragraph in the same manner as they apply to a civil money penalty or proceeding undersection 1320a?7a(a) of this title. (10) Con f iden t ialit y of in f or m at ion Notwithstanding any other provision of law, information disclosed by a laboratory under this subsection is confidential and shall not be disclosed by the Secretary or a Medicare contractor in a form that discloses the identity of a specific payor or laboratory, or prices charged or payments made to any such laboratory, except·(A) as the Secretary determines to be necessary to carry out this section; ·(B) to permit the Comptroller General to review the information provided; ·(C) to permit the Director of the Congressional Budget Office to review the information provided; and 11

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text ·(C) to permit the Director of the Congressional Budget Office to review the information provided; and ·(D) to permit the Medicare Payment Advisory Commission to review the information provided. (11) Pr ot ect ion f r om pu blic disclosu r e A payor shall not be identified on information reported under this subsection. The name of an applicable laboratory under this subsection shall be exempt from disclosure undersection 552(b)(3) of title 5. (12) Regu lat ion s Not later than June 30, 2015, the Secretary shall establish through notice and comment rulemaking parameters for data collection under this subsection. (b) Paym en t f or clin ical diagn ost ic labor at or y t est s (1) Use of pr ivat e payor r at e in f or m at ion t o det er m in e m edicar e paym en t r at es (A) In gen er al ·Subject to paragraph (3) and subsections (c) and (d), in the case of a clinical diagnostic laboratory test furnished on or after January 1, 2017, the payment amount under this section shall be equal to the weighted median determined for the test under paragraph (2) for the most recent data collection period. (B) Applicat ion of paym en t am ou n t s t o h ospit al labor at or ies ·The payment amounts established under this section shall apply to a clinical diagnostic laboratory test furnished by a hospital laboratory if such test is paid for separately, and not as part of a bundled payment undersection 1395l(t) of this title. (2) Calcu lat ion of w eigh t ed m edian For each laboratory test with respect to which information is reported under subsection (a) for a data collection period, the Secretary shall calculate a weighted median for the test for the period, by arraying the distribution of all payment rates reported for the period for each test weighted by volume for each payor and each laboratory. (3) Ph ase-in of r edu ct ion s f r om pr ivat e payor r at e im plem en t at ion (A) In gen er al ·Payment amounts determined under this subsection for a clinical diagnostic laboratory test for each of 2017 through 2025 shall not result in a reduction in payments for a clinical diagnostic laboratory test for the year of greater than the applicable percent (as defined in subparagraph (B)) of the amount of payment for the test for the preceding year. (B) Applicable per cen t def in ed ·In this paragraph, the term "applicable percent" means(i) for each of 2017 through 2020, 10 percent;

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (B) Applicable per cen t def in ed ·In this paragraph, the term "applicable percent" means(i) for each of 2017 through 2020, 10 percent; (ii) for each of 2021 and 2022, 0 percent; and (iii) for each of 2023 through 2025, 15 percent. (C) No applicat ion t o n ew t est s ·This paragraph shall not apply to payment amounts determined under this section for either of the following. (i) A new test under subsection (c). (ii) A new advanced diagnostic test 1(as defined in subsection (d)(5)) under subsection (d). (4) Applicat ion of m ar k et r at es (A) In gen er al ·Subject to paragraph (3), once established for a year following a data collection period, the payment amounts under this subsection shall continue to apply until the year following the next data collection period. (B) Ot h er adju st m en t s n ot applicable ·The payment amounts under this section shall not be subject to any adjustment (including any geographic adjustment, budget neutrality adjustment, annual update, or other adjustment). (5) Sam ple collect ion f ee In the case of a sample collected from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, the nominal fee that would otherwise apply undersection 1395l(h)(3)(A) of this titleshall be increased by $2. (c) Paym en t f or n ew t est s t h at ar e n ot advan ced diagn ost ic labor at or y t est s (1) Paym en t du r in g in it ial per iod In the case of a clinical diagnostic laboratory test that is assigned a new or substantially revised HCPCS code on or after April 1, 2014, and which is not an advanced diagnostic laboratory test (as defined in subsection (d)(5)), during an initial period until payment rates under subsection (b) are established for the test, payment for the test shall be determined·(A) using cross-walking (as described in section 414.508(a) of title 42, Code of Federal Regulations, or any successor regulation) to the most appropriate existing test under the fee schedule under this section during that period; or(B) if no existing test is comparable to the new test, according to the gap filling process described in paragraph (2).

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (2) Gapf illin g pr ocess descr ibed The gapfilling process described in this paragraph shall take into account the following sources of information to determine gapfill amounts, if available: ·(A) Charges for the test and routine discounts to charges. ·(B) Resources required to perform the test. ·(C) Payment amounts determined by other payors. ·(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant. ·(E) Other criteria the Secretary determines appropriate. (3) Addit ion al con sider at ion In determining the payment amount under crosswalking or gapfilling processes under this subsection, the Secretary shall consider recommendations from the panel established under subsection (f)(1). (4) Explan at ion of paym en t r at es In the case of a clinical diagnostic laboratory test for which payment is made under this subsection, the Secretary shall make available to the public an explanation of the payment rate for the test, including an explanation of how the criteria described in paragraph (2) and paragraph (3) are applied. (d) Paym en t f or n ew advan ced diagn ost ic labor at or y t est s (1) Paym en t du r in g in it ial per iod (A) In gen er al ·In the case of an advanced diagnostic laboratory test for which payment has not been made under the fee schedule undersection 1395l(h) of this titleprior to April 1, 2014, during an initial period of three quarters, the payment amount for the test for such period shall be based on the actual list charge for the laboratory test. (B) Act u al list ch ar ge ·For purposes of subparagraph (A), the term "actual list charge", with respect to a laboratory test furnished during such period, means the publicly available rate on the first day at which the test is available for purchase by a private payor. (2) Special r u le f or t im in g of in it ial r epor t in g With respect to an advanced diagnostic laboratory test described in paragraph (1)(A), an applicable laboratory shall initially be required to report under subsection (a) not later than the last day of the second quarter of the initial period under such paragraph. 14

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (3) Applicat ion of m ar k et r at es af t er in it ial per iod Subject to paragraph (4), data reported under paragraph (2) shall be used to establish the payment amount for an advanced diagnostic laboratory test after the initial period under paragraph (1)(A) using the methodology described in subsection (b). Such payment amount shall continue to apply until the year following the next data collection period. (4) Recou pm en t if act u al list ch ar ge exceeds m ar k et r at e With respect to the initial period described in paragraph (1)(A), if, after such period, the Secretary determines that the payment amount for an advanced diagnostic laboratory test under paragraph (1)(A) that was applicable during the period was greater than 130 percent of the payment amount for the test established using the methodology described in subsection (b) that is applicable after such period, the Secretary shall recoup the difference between such payment amounts for tests furnished during such period. (5) Advan ced diagn ost ic labor at or y t est def in ed In this subsection, the term "advanced diagnostic laboratory test" means a clinical diagnostic laboratory test covered under this part that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and meets one of the following criteria: ·(A) The test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result. ·(B) The test is cleared or approved by the Food and Drug Administration. ·(C) The test meets other similar criteria established by the Secretary. (e) Codin g (1) Tem por ar y codes f or cer t ain n ew t est s (A) In gen er al ·The Secretary shall adopt temporary HCPCS codes to identify new advanced diagnostic laboratory tests (as defined in subsection (d)(5)) and new laboratory tests that are cleared or approved by the Food and Drug Administration. (B) Du r at ion (i) In gen er al Subject to clause (ii), the temporary code shall be effective until a permanent HCPCS code is established (but not to exceed 2 years). (ii) Except ion The Secretary may extend the temporary code or establish a permanent HCPCS code, as the Secretary determines appropriate. 15

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (2) Exist in g t est s Not later than January 1, 2016, for each existing advanced diagnostic laboratory test (as so defined) and each existing clinical diagnostic laboratory test that is cleared or approved by the Food and Drug Administration for which payment is made under this part as of April 1, 2014, if such test has not already been assigned a unique HCPCS code, the Secretary shall·(A) assign a unique HCPCS code for the test; and ·(B) publicly report the payment rate for the test. (3) Est ablish m en t of u n iqu e iden t if ier f or cer t ain t est s For purposes of tracking and monitoring, if a laboratory or a manufacturer requests a unique identifier for an advanced diagnostic laboratory test (as so defined) or a laboratory test that is cleared or approved by the Food and Drug Administration, the Secretary shall utilize a means to uniquely track such test through a mechanism such as a HCPCS code or modifier. (f ) In pu t f r om clin ician s an d t ech n ical exper t s (1) In gen er al The Secretary shall consult with an expert outside advisory panel, established by the Secretary not later than July 1, 2015, composed of an appropriate selection of individuals with expertise, which may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics, in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests, to provide·(A) input on(i) the establishment of payment rates under this section for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test; and (ii) the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and ·(B) recommendations to the Secretary under this section. (2) Com plian ce w it h FACA The panel shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.). (3) Con t in u at ion of an n u al m eet in g The Secretary shall continue to convene the annual meeting described insection 1395l(h)(8)(B)(iii) of this titleafter the implementation of this section for purposes of receiving comments and recommendations (and data on which the recommendations are based) as described in such section on the establishment of payment amounts under this section. (g) Cover age (1) Issu an ce of cover age policies

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (g) Cover age (1) Issu an ce of cover age policies (A) In gen er al ·A medicare administrative contractor shall only issue a coverage policy with respect to a clinical diagnostic laboratory test in accordance with the process for making a local coverage determination (as defined insection 1395ff(f)(2)(B) of this title), including the appeals and review process for local coverage determinations under part 426 of title 42, Code of Federal Regulations (or successor regulations). (B) No ef f ect on n at ion al cover age det er m in at ion pr ocess ·This paragraph shall not apply to the national coverage determination process (as defined insection 1395ff(f)(1)(B) of this title). (C) Ef f ect ive dat e ·This paragraph shall apply to coverage policies issued on or after January 1, 2015. (2) Design at ion of on e or m or e m edicar e adm in ist r at ive con t r act or s f or clin ical diagn ost ic labor at or y t est s The Secretary may designate one or more (not to exceed 4) medicare administrative contractors to either establish coverage policies or establish coverage policies and process claims for payment for clinical diagnostic laboratory tests, as determined appropriate by the Secretary. (h ) Im plem en t at ion (1) Im plem en t at ion There shall be no administrative or judicial review undersection 1395ff of this title,section 1395oo of this title, or otherwise, of the establishment of payment amounts under this section. (2) Adm in ist r at ion Chapter 35 of title 44shall not apply to information collected under this section. (3) Fu n din g For purposes of implementing this section, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund undersection 1395t of this title, to the Centers for Medicare & Medicaid Services Program Management Account, for each of fiscal years 2014 through 2018, $4,000,000, and for each of fiscal years 2019 through 2023, $3,000,000. Amounts transferred under the preceding sentence shall remain available until expended. (i) Tr an sit ion al r u le During the period beginning on April 1, 2014, and ending on December 31, 2016, with respect to advanced diagnostic laboratory tests under this part, the Secretary shall use the methodologies for pricing, coding, and coverage in effect on the day before April 1, 2014, which may include cross-walking or gap filling methods. 17

PARA Weekly eJournal: July 27, 2022

CHANGES IN THE WIND? PROPOSED LEGISLATION MAY CHANGE PAMA RULES

Her e Is Th e Com plet e Text (Aug. 14, 1935, ch. 531, title XVIII, §1834A, as addedPub. L. 113?93, title II, §216(a), Apr. 1, 2014, 128 Stat. 1053; amendedPub. L. 116?94, div. N, title I, §105(a), Dec. 20, 2019, 133 Stat. 3100;Pub. L. 116?136, div. A, title III, §3718, Mar. 27, 2020, 134 Stat. 425;Pub. L. 117?71, §4, Dec. 10, 2021, 135 Stat. 1507.) Edit or ial Not es Ref er en ces in Text The Federal Advisory Committee Act, referred to in subsec. (f)(2), isPub. L. 92?463, Oct. 6, 1972, 86 Stat. 770, which is set out in the Appendix to Title 5, Government Organization and Employees. Am en dm en t s 2021-Subsec. (a)(1)(B)(i). Pub. L. 117?71, §4(b)(1), substituted "December 31, 2022" for "December 31, 2021". Subsec. (a)(1)(B)(ii). Pub. L. 117?71, §4(b)(2), substituted "January 1, 2023" for "January 1, 2022" and "March 31, 2023" for "March 31, 2022". Subsec. (b)(3)(A). Pub. L. 117?71, §4(a)(1), substituted "through 2025" for "through 2024". Subsec. (b)(3)(B)(ii). Pub. L. 117?71, §4(a)(2)(A), substituted "for each of 2021 and 2022" for "for 2021". Subsec. (b)(3)(B)(iii). Pub. L. 117?71, §4(a)(2)(B), substituted "2023 through 2025" for "2022 through 2024". 2020-Subsec. (a)(1)(B)(i). Pub. L. 116?136, §3718(a)(1), substituted "December 31, 2021" for "December 31, 2020". Subsec. (a)(1)(B)(ii). Pub. L. 116?136, §3718(a)(2), substituted "January 1, 2022" for "January 1, 2021" and "March 31, 2022" for "March 31, 2021". Subsec. (b)(3)(A). Pub. L. 116?136, §3718(b)(1), substituted "through 2024" for "through 2023". Subsec. (b)(3)(B). Pub. L. 116?136, §3718(b)(2), added cl. (ii), redesignated former cl. (ii) as (iii), and substituted "2022 through 2024" for "2021 through 2023" in cl. (iii). 2019-Subsec. (a)(1). Pub. L. 116?94, §105(a)(1)(A), designated existing provisions as subpar. (A) and inserted heading, substituted "Subject to subparagraph (B), beginning January 1, 2016" for "Beginning January 1, 2016", inserted "(referred to in this subsection as the 'reporting period')" after "at a time specified by the Secretary", and added subpar. (B). Subsec. (a)(4). Pub. L. 116?94, §105(a)(1)(B), designated existing provisions as subpar. (A) and inserted heading, substituted "Subject to subparagraph (B), in this section" for "In this section", and added subpar. (B). Subsec. (b)(3)(A). Pub. L. 116?94, §105(a)(2)(A), substituted "through 2023" for "through 2022". Subsec. (b)(3)(B)(i). Pub. L. 116?94, §105(a)(2)(B)(i), substituted "through 2020" for "through 2019".Subsec. (b)(3)(B)(ii). Pub. L. 116?94, §105(a)(2)(B)(ii), substituted "2021 through 2023" for "2020 through 2022".

PARA Weekly eJournal: July 27, 2022

FDA APPROVES EUA FOR NOVAVAX ADJUVANTED COVID-19 VACCINE

On July 13, 2022, the FDA granted an Emergency Use Authorization (EUA) for Adjuvanted produced by Novavax. The two-dose series, administered three weeks apart is authorized for the prevention of COVID-19 in patients 18 and older.

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019covid-19/novavax-covid-19-vaccine-adjuvanted

Th e t w o-dose ser ies, adm in ist er ed t h r ee w eek s apar t is au t h or ized f or t h e pr even t ion of COVID-19 in pat ien t s 18 an d older .

PARA Weekly eJournal: July 27, 2022

FDA APPROVES EUA FOR NOVAVAX ADJUVANTED COVID-19 VACCINE

For other COVID-19 vaccine and administration codes, please see Par aRev ?s updated COVID-19 Vaccine Product and Administration paper:

PARA Weekly eJournal: July 27, 2022

MPFS PROPOSED RULE ADDS ANOTHER MODIFIER FOR PAYABLE DRUGS

CMShasproposedthat hospital , physician, and Ambul atory Surgery Center cl aims reportingexpensive drugs(OPPSStatus KandG)appendanewmodifier -- JZ-- tothedrugHCPCSwhennoportionof a singl e-usevial iscl aimedaswaste. The proposal is discussed beginning on page 491 of the unpublished version of the CY 2023 Payment Policies under the Physician Fee Schedule: https://www.federalregister.gov/public-inspection/2022-14562/medicare-and-medicaidprograms-calendar-year-2023-payment-policies-under-the-physician-fee-schedule

Currently, hospitals are required to report the wasted portion of expensive drugs on a separate line with modifier JW appended to the HCPCS, but if no wasted portion of a single-use vial is claimed, neither a modifier nor a second line reporting the drug is required.New modifier JZ would be appended to the single-line HCPCS when no second line of wastage would be claimed, to verify that no portion was wasted. For example, if the proposed rule is adopted, when the full contents of a 2-milligram vial of CathFlow ® , J2997, is used for a declotting procedure, a claim to Medicare would append modifier JZ to J2997 as indicated in this screen shot from the PARA Dat a Edit or : (see next page)

PARA Weekly eJournal: July 27, 2022

MPFS PROPOSED RULE ADDS ANOTHER MODIFIER FOR PAYABLE DRUGS

CMS hopes the modifier will improve billing data needed to facilitate refunds from drug manufacturers for wasted drugs. The Infrastructure Investment and Jobs Act (Pub. L. 117-9, November 15, 2021) requires drug manufacturers to issue a refund to CMS for certain discarded amounts from certain single-dose container or single-use package drug. To claim the maximum refund, CMS needs accurate data, and seeks to improve reporting from hospitals to ensure the refund amounts are appropriate. Medicare?s proposed rule indicates they are not confident the data from the JW modifier is adequate: ?Under our current discarded drug policy, no modifier is required when there are no discarded amounts from a single use vial or single use package drug. However, we are aware that the JW modifier is often omitted on claims, and it is unclear whether the absence of the JW modifier on a claim for a single-dose container drug indicates that there were no discarded amounts or that the modifier was incorrectly omitted from the claim. This has led to incomplete data describing quantities of discarded amounts and the associated Medicare payments.?? Because JW modifier data is incomplete and because refund amounts would rely on this data, we propose that for dates of service on or after January 1, 2023, the JW modifier be required on claims for all single-dose container or single use drugs for which any amount is discarded (as reflected in our current policy and proposed above), and a separate modifier be required on claims for these drugs when there are no discarded amounts. Specifically, we propose to require the use of a separate modifier, the JZ modifier, to attest that there were no discarded amounts.?

PARA Weekly eJournal: July 27, 2022

MPFS PROPOSED RULE ADDS ANOTHER MODIFIER FOR PAYABLE DRUGS

Since 2017, Medicare has required hospitals to report the wasted portion of a single-use vial on a second line item for each payable drug HCPCS. The second line, with modifier JW appended to the drug HCPCS, allows CMS to monitor wastage while permitting the provider to receive reimbursement for the entire vial contents. If the new proposed rule is adopted, hospitals would report the JZ modifier if no wastage was claimed, for instance if an entire vial was administered to the patient. A new claim edit would reject any claim for an OPPS status K or G drug which failed to report either 1) the JZ modifier, or 2) a second line of the same HCPCS with modifier JW appended. Her e ar e a f ew m or e excer pt s f r om t h e n ar r at ive of t h e pr oposed r u le: ?More than half of Medicare spending for discarded amounts in 2020 represents about 40 billing and payment codes (that is, HCPCS codes), for which 10 percent or more of the total charges for the drug were for discarded units. A large proportion of single source drugs with 10 percent or more discarded units are dosed based on patient?s body weight or BSA. We note that the JW modifier data published on the CMS website is limited to only billing and payment codes that are published on the ASP Drug Pricing File. There are likely additional billing and payment codes payable under Medicare Part B available in single-dose containers that would be subject to the JW modifier policy and are not reflected in the data discussed above.? " ?? Because JW modifier data is incomplete and because refund amounts would rely on this data, we propose that for dates of service on or after January 1, 2023, the JW modifier be required on claims for all single-dose container or single use drugs for which any amount is discarded (as reflected in our current policy and proposed above), and a separate modifier be required on claims for these drugs when there are no discarded amounts. Specifically, we propose to require the use of a separate modifier, the JZ modifier, to attest that there were no discarded amounts. To align with the JW modifier policy, the JZ modifier would be required when there are no discarded amounts from single use vials or single use packages payable under Part B for which the JW modifier would be required if there were discarded amounts. So, on all claims for single use vials or single use packages payable under Part B, either the JW modifier would be used (on a separate line) to identify any discarded amounts or the JZ modifier (on the claim line with the administered amount) would be present to attest that there were no discarded amounts. We believe the proposed JZ modifier requirement would not increase burden on the provider because under the current JW modifier policy, the provider already needs to determine whether or not there are any discarded units from a single use vial or package, record discarded amounts in the patient medical record, and specify administered and discarded amounts on the claim form." CMS seeks comments on the proposed rule. Comments may be submitted after the final publication of the proposed rule, expected on 7/29/2022. Interested parties may submit electronic comments on the proposed rule to http://www.regulations.gov. Follow the ?Submit a comment? instructions. 23

PARA Weekly eJournal: July 27, 2022

RHC AND FQHC MENTAL HEALTH TELEHEALTH VISITS FOLLOWING PHE

On June 6, 2022, in MLN Article, "Mental Health Visits via Telecommunications for Rural Health Clinics & Federally Qualified Health Centers," CMS revised in-person requirements for Mental Health Visits via Telecommunication for RHCs and FQHCs following the COVID-19 Public Health Emergency (PHE). Per Section 304 of the Consolidated Appropriations Act (CAA) 2022, when a Medicare beneficiary receives mental health visits via telecommunications, RHCs and FQHCs will not require in-person visits until the 152nd day following the COVID-19 PHE. The exception applies only to RHC and FQHC mental health services; all other providers must abide by the following Medicare requirements? No other changes were made to the mental health visit telehealth requirements. The exception applies only to RHC and FQHC mental health services; all other providers must abide by the following Medicare in-person visit requirements for beneficiaries receiving mental health visits via telecommunications: - At least 6 months prior to a telecommunication visit for mental health - With limited exceptions, at least every 12 months during mental health telecommunications to diagnose, evaluate or treat the patient's mental health issues and conditions

PARA Weekly eJournal: July 27, 2022

RHC AND FQHC MENTAL HEALTH TELEHEALTH VISITS FOLLOWING PHE

CMS provides a non-exclusive list of exceptions to the 12-month in-person visit when:

- The patient is in full or partial remission and needs only maintenance care - The patient's condition may worsen, or an in-person visit may be disruptive - The patient's care has been effective, but the patient may stop care with a required in-person visit - The practitioner considers the patient clinically stable, but an in-person visit could impair the progress or create an undue hardship for the patient or the patient's family Practitioners need to document circumstances leading to exceptions of the in-person visit. Additional information is available through the following links: Mental Health Visits via Telecommunications for Rural Health Clinics & Federally Qualified Health Centers

Section 304 of the Consolidated Appropriations Act (CAA) 2022

PARA Weekly eJournal: July 27, 2022

PATIENT PREVAILS IN NSA DISPUTE WITH FACILITY

A miscommunication cost a facility $3,000 when a Good Faith Estimate (GFE) was issued to an uninsured patient with an incorrect CPT® . The cardiologist had scheduled a procedure but did not list the code for the intended procedure. The GFE was issued to the patient with a code that was priced $3,000 less than the intended procedure. The patient initiated a Patient Provider Dispute Resolution (PPDR) and prevailed when the facility was unable to produce supportive evidence of not having reasonably expected the increased charges. The facility has allowed Par aRev to share the communication they received from CMS to allow other facilities and providers to prepare for potential PPDR events. CMS used the email FederalPPDRinititation@cms.hhs.gov to send correspondences to facilities and providers to inform them that a patient has initiated a dispute and provide further instructions. Par aRev strongly encourages clients to add this email address to their address book to avoid having these notices go to spam folders.

PARA Weekly eJournal: July 27, 2022

PATIENT PREVAILS IN NSA DISPUTE WITH FACILITY

The hyperlink in the email message took the facility to a CMS portal where they could complete an electronic form and upload the required documents.

PARA Weekly eJournal: July 27, 2022

PATIENT PREVAILS IN NSA DISPUTE WITH FACILITY

According to the provider, the portal did not allow the facility to upload documents even though they were under the 500MB limit. They were able to contact CMS to get an address in which to send hard copies of documents. These are the updates shared internally at the facility.

PARA Weekly eJournal: July 27, 2022

PATIENT PREVAILS IN NSA DISPUTE WITH FACILITY

The next correspondence received by the facility was from the third party entity which adjudicated the case. That entity provided the facility with a detailed explanation of their findings and determination. That message is shared below.

PARA Weekly eJournal: July 27, 2022

PATIENT PREVAILS IN NSA DISPUTE WITH FACILITY

This expensive error can be avoided in 2022 with good communication between convening facilities and ordering providers. In 2023 the convening facility/provider will have to include charges from co-providers which will include the primary service code and avoid costly errors. The following excerpt is provided from the regulations. It outlines what information must be provided from the co-facility/provider to the convening facility/provider. eCFR :: 45 CFR 149.610 -- Requirements for provision of good faith estimates of expected charges for uninsured (or self-pay) individuals. Content Requirements for Good Faith Estimate Information Submitted by Co-Providers or Co-Facilities to Convening Providers or Convening Facilities. (1) Good faith estimate information submitted to convening providers or convening facilities by co-providers or co-facilities for inclusion in the good faith estimate (described inparagraph (c)(1)of this section) must include: (i) Patient name and date of birth; (ii) Itemized list of items or services expected to be provided by the co-provider or co-facility that are reasonably expected to be furnished in conjunction with the primary item or service as part of the period of care; (iii) Applicable diagnosis codes, expected service codes, and expected charges associated with each listed item or service; (iv) Name, National Provider Identifiers, and Tax Identification Numbers of the co-provider or co-facility, and the State(s) and office or facility location(s) where the items or services are expected to be furnished by the co-provider or co-facility; and(v) A disclaimer that the good faith estimate is not a contract and does not require the uninsured (or self-pay) individual to obtain the items or services from any of the co-providers or co-facilities identified in the good faith estimate.

PARA Weekly eJournal: July 27, 2022

SUPREME COURT INVALIDATES 2018-2019 340(B) PAYMENT CUTS

On June15, 2022, t heSupr emeCour t of t he Unit ed St at es (SCOTUS) issued a decision t hat Medicar eimpr oper ly r educed OPPSr eimbur sement t o cer t ain hospit al s which pur chasedr ugs under HRSA?s 340(b) pr ogr am in 2018 and 2019. The full text of the court?s decision is available at https://www.supremecourt.gov/opinions/ 21pdf/20-1114_09m1.pdf.) Th e good n ew s is that hospitals which endured reduced Medicare payments for drugs purchased under the 340(b) program may eventually recover the 340(b) cuts to reimbursement taken by Medicare in 2018 and 2019 ? although how and when that might happen is not yet determined. Th e bad n ew s is that due to budget neutrality requirements, reversing the current payment policy could cause Medicare to fund the additional expense by cutting OPPS reimbursement in other areas. According to a study commissioned by the Federation of American Hospitals, even rural OPPS hospitals that were exempted from the 340(b) cuts could eventually be affected by the fallout: https://avalere.com/insights/opps-340b-policy-reversal-lowers-hospital-paymentand-increases-copays# ? nearly half (49.4%) of all OPPS 340B hospitals would see a net payment decrease in total OPPS payments under a policy reversal. This occurs because the corresponding budget neutrality payment reduction for all non-drug items and services would outweigh the drug payment increase. The aggregate beneficiary cost-sharing amount for separately payable drugs across all OPPS 340B hospitals is estimated to increase by $472.8 million under a policy reversal. Of note, the specific cost-sharing amount a beneficiary pays for a drug or a service under OPPS is capped at the amount of inpatient hospital deductible, which is $1,484 in 2021.

PARA Weekly eJournal: July 27, 2022

SUPREME COURT INVALIDATES 2018-2019 340(B) PAYMENT CUTS

Par aRev clients may assess the impact of the 340(b) reductions by reviewing the outpatient claim lines adjudicated by original Medicare in prior years, namely 2018 and 2019, on the CMS tab of the PARA Dat a Edit or . Simply enter ?JG? in the modifier field, and download (with detail) a list of claims paid by CMS according to CMS published data for 2019 and 2020.The data is exactly as published by Medicare in the MEDPAR Limited Data Set.

The downloaded spreadsheet offers two tabs - a list of claims (Headers), and line item details:

PARA Weekly eJournal: July 27, 2022

SUPREME COURT INVALIDATES 2018-2019 340(B) PAYMENT CUTS

On the Det ails tab, clients can filter the results to only those line items reported with modifier JG; the sum of the CMS Payment Amount, beneficiary deductible, and beneficiary coinsurance is the total ?allowed? amount that was reduced under the 340(b) cuts:

The American Hospital Association published a Special Bulletin on June 15, 2022 stating that ?Now that the Supreme Court has ruled, we look forward to working with the Administration and the courts to develop a plan to reimburse 340B hospitals affected by these unlawful cuts while ensuring the remainder of the hospital field is not disadvantaged as they also continue to serve their communities.? https://www.aha.org/system/files/media/file/2022/06/2022-0615-Special-Bulletin -340B-Supreme-Court-Decision.pdf

PARA Weekly eJournal: July 27, 2022

SUPREME COURT INVALIDATES 2018-2019 340(B) PAYMENT CUTS

According to the AHA bulletin, the Supreme Court concluded that ?[u]nder the text and structure of the statute,? the case was ?straightforward? as a matter of law: ? Because HHS did not conduct a survey of hospitals?acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.? (Although rates in 2020 could arguably be affected by the SCOTUS decision, reimbursement rates in 2021 and 2022 are not covered because CMS conducted a survey of hospital acquisition costs for those years.) Beginning January 1, 2018, Medicare reduced OPPS reimbursement for separately payable (Status K) drugs purchased under the 340(b) program at certain hospitals. In 2018, CMS adjusted the reimbursement amount for 340(b) drugs at the average sales price (ASP) minus 28.5 percent, although certain hospitals were excepted from the payment adjustment policy.In 2019, CMS dropped the reduction to ASP minus 22.5%. Drugs that were not acquired through the 340(b) program were paid under the OPPS at ASP+6 percent in both 2018 and 2019. Affected hospitals are required to append modifier ?JG? (Drug or biological acquired with 340B drug pricing program discount) to outpatient claims reporting payable drugs to facilitate the discounted rate of payment. In 2019, CMS calculated payments made on drug charges with the JG modifier appended at .775 of the ASP (in other words, ASP minus 22.5%.) That rate is lower than standard OPPS methodology of 106% ASP (ASP plus 6%.) Therefore, for every $100 in allowable paid on lines reporting modifier JG in 2019, affected hospitals might recover an additional $36.77. However, since 20% of the allowable would have been adjudicated to beneficiary liability, there will be some negotiation over the precise amount that CMS will pay ? and where the money will come from, since budget neutrality requires the additional payments to be offset from other OPPS expenditures.

PARA Weekly eJournal: July 27, 2022

HHS EXTENDS PHE THROUGH OCTOBER 13, 2022

On July 15, 2022, Xavier Becerra, the Secretary of Health and Human Services, renewed the national Public Health Emergency (PHE) again for up to an additional 90-day period. This latest extension will expire on Oct ober 13, 2022, unless the HHS Secretary determines the PHE is over or extends the PHE. https://aspr.hhs.gov/legal/PHE/Pages/covid19-15jul2022.aspx

PARA Weekly eJournal: July 27, 2022

HHS EXTENDS PHE THROUGH OCTOBER 13, 2022

The PHE Declar at ion Qu est ion s an d An sw er s webpage states that the PHE may be terminated either at the end of the 90-day extension or until the HHS Secretary declares the PHE no longer exists: https://www.phe.gov/Preparedness/legal/Pages/phe-qa.aspx#faq7

In a letter dated 01/01/2021, HHS informed state governors that the HHS will provide a 60-day notice before ending the PHE. We provide an excerpt on the following page. https://ccf.georgetown.edu/wp-content/uploads/2021/01/Public-Health-EmergencyMessage-to-Governors.pdf

PARA Weekly eJournal: July 27, 2022

MLN CONNECTS

PARA in vit es you t o ch eck ou t t h e m ln con n ect s page available f r om t h e Cen t er s For M edicar e an d M edicaid (CM S). It 's ch ock f u ll of n ew s an d in f or m at ion , t r ain in g oppor t u n it ies, even t s an d m or e! Each w eek PARA w ill br in g you t h e lat est n ew s an d lin k s t o available r esou r ces. Click each lin k f or t h e PDF!

Th u r sday, Ju ly 21, 2022 New s -

988 Suicide & Crisis Lifeline Availablel Nationwide

COVID-19: Novavax Vaccine, Adjuvanted ? New Codes

Allergy & Immunology: Comparative Billing Report in July

Inpatient Rehabilitation Facilities: Care Compare July Refresh

Long-Term Care Hospitals: Care Compare July Refresh

Hospices & Home Health Agencies: Submit Technical Expert Panel Nominations by August 12

Skilled Nursing Facility Provider Preview Reports: Review by August 15

Opioid Treatment Programs: Comment by September 6

Com plian ce -

Implanted Spinal Neurostimulators: Document Medical Records

In f or m at ion f or Pat ien t s -

Medicare Savings Programs Help Pay Premiums

PARA Weekly eJournal: July 27, 2022

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Ther e w er e THREE new or r evised Tr ansmittal s r el eased this w eek . To go to the ful l Tr ansmittal document simpl y cl ick on the scr een shot or the l ink .

PARA Weekly eJournal: July 27, 2022

TRANSMITTAL R11504CP

PARA Weekly eJournal: July 27, 2022

TRANSMITTAL R11505DEMO

PARA Weekly eJournal: July 27, 2022

TRANSMITTAL R11503OTN

PARA Weekly eJournal: July 27, 2022

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PARA Weekly eJournal: July 27, 2022

FOR YOUR INFORMATION

The preceding materials are for instructional purposes only. The information is presented "as-is" and to the best of ParaRev?s knowledge is accurate at the time of distribution. However, due to the ever changing legal/regulatory landscape this information is subject to modification, as statutes/laws/regulations or other updates become available. Nothing herein constitutes, is intended to constitute, or should be relied on as, legal advice. ParaRev expressly disclaims any responsibility for any direct or consequential damages related in any way to anything contained in the materials, which are provided on an ?as-is?basis and should be independently verified before being applied. You expressly accept and agree to this absolute and unqualified disclaimer of liability.The information in this document is confidential and proprietary to ParaRev and is intended only for the named recipient. No part of this document may be reproduced or distributed without express permission. Permission to reproduce or transmit in any form or by any means electronic or mechanical, including presenting, photocopying, recording and broadcasting, or by any information storage and retrieval system must be obtained in writing from ParaRev. Request for permission should be directed to sales@pararevenue.com.

Par aRev is excited to announce we have joined industry leader Cor r oHealt h to enhance the reach of our offerings! Par aRev services lines are additive in nature strengthening Cor r oHealt h?s impact to clients?revenue cycle. In addition, you now have access to a robust set of mid-cycle tools and solutions from Cor r oHealt h that complement Par aRev offerings. In terms of the impact you?ll see, there will be no change to the management or services we provide. The shared passion, philosophy and cultures of our organizations makes this exciting news for our team and you, our clients. While you can review the Cor r oHealt h site HERE, we can coordinate a deeper dive into any of these solutions. Simply let us know and we?ll set up a meeting to connect. As always, we are available to answer any questions you may have regarding this news. We thank you for your continued partnership.